HeadacheNCT04950413
Instrument-assisted Soft Tissue Mobilization and Phonophoresis on Trigger Points of Tension Headache
A study testing Conventional physical therapy program, IASTM by M2t blade and Phonophoresis in people with Headache and Tension-Type Headache, run by Nada Gamal Saad at 1 site in Egypt.
Trial summary
General purpose: It was investigate the effect of IASTM and phonophoresis on Tension Type headache. Specific Purpose: 1. It was investigate the effect of IASTM on headache frequency, PPT, pain intensity, and functional disability on trigger points of tension type headache. 2. Read more about this study
- Who is it for?
- Ages 30 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Headache, Tension-Type Headache
- What is being tested?
- Conventional physical therapy program, IASTM by M2t blade and Phonophoresis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 30 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Their age ranged from 30 to 40 years.
- BMI ranged from 18 to 25 kg /m2.
- TTH criteria according to the Headache Classification Committee of the International Headache Society has at least two of the following characteristics:
- Bilateral location.
- Pressing/tightening quality (non-pulsating).
- Mild or moderate intensity.
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- Not aggravated by routine physical activity such as walking or climbing stairs.
- Patients have Trigger points in suboccipital muscle and trigger points 1 trapezius muscle.
- The presence of MTrPs will be determined using the diagnostic criteria described by Simons 1990, in which five major criteria and at least one of three minor criteria are needed for a clinical diagnosis of MPS.
Who cannot join
- Patients with a history of malignancy.
- Patients who had a history of cervical and cranial Surgery.
- Patients with major psychiatric disorders (major Depression).
- Patients with uncontrolled hypertension
- Patient with other causes of headache.
- Dysfunctions in the temporomandibular joint.
- Headaches associated with high fever, stiff neck, or rash, problems with vision, or profound dizziness.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient clinic - Faculty of Physical Therapy - Cairo University
Dokki, 12611
About this study
Official title: Effect of Instrument-assisted Soft Tissue Mobilization and Phonophoresis on Trigger Points of Tension Headache
General purpose:
It was investigate the effect of IASTM and phonophoresis on Tension Type headache.
Specific Purpose:
- It was investigate the effect of IASTM on headache frequency, PPT, pain intensity, and functional disability on trigger points of tension type headache.
- It was investigate the effect of Lidocaine phonophoresis on headache frequency, PPT, pain intensity and functional disability on trigger points of tension type headache.
- It was investigate the effect of IASTM and Lidocaine phonophoresis on headache frequency, PPT, pain intensity, and functional disability on trigger points of tension type headache.
Read the detailed description
Phonophoresis is the use of therapeutic ultrasound to increase percutaneous drug absorption Percutaneous administration offers many benefits such as steady plasma levels, lack of degradation by the gastrointestinal system, and lack of liver effects (first-pass drug metabolism) on drug molecules. Transdermal drug delivery offers a unique opportunity for non-invasive and controlled drug delivery, in contrast to needle-based and oral drug administration. Phonophoresis is a therapeutic method that may be helpful for the treatment of MTP.
There are potentially adverse treatment responses to ISTM that may occur. The patient may experience discomfort during the administration of the treatment, and petechiae (i.e., bruising) may become apparent during or after the treatment Although discomfort may be experienced, patients who have realized a decrease in symptoms have returned repeatedly for additional ISTM sessions other therapeutic modalities should be administered for pain management.
Clinical and scientific evidence supports that proper management of patients with headache should be multimodal including appropriate use of pharmacological and non-pharmacological.IASTM used to facilitate normal alignment of soft tissue and increase fibroblast recruitment and regeneration of damaged tissue. Phonophoresis is frequently used to treat pain associated with muscular disorders, enhancing skin absorption of the topical medication's molecules. Study report that lidocaine decreases sensory input from mrofascialTrps and release local Tenderness by lowering the degree of the reflex mechanism responsible for referred pain.
- Conditions
- Headache, Tension-Type Headache
- Being tested
- Conventional physical therapy program, IASTM by M2t blade, Phonophoresis
- Medical subject headings
- Headache, Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional physical therapy programOther
Infrared, Exercises, Stretching exercise of Suboccepital muscle
IASTM by M2t bladeOther
A lubricant (Vaseline) will be applied to the skin around the neck area prior to treatment and the M2t blade will be cleaned with an alcohol pad. First, the M2T blade will used to find the exact areas of restriction in affected muscles. Then the M2T blade will use at an angle of 45 to apply slow strokes along the muscle. Changes in soft tissue consistency will detected by the clinician through vibrations of the instrument when it slides on areas of irregular fibrosis of the underneath connective tissue. Once an adhesion is discovered, strokes are repeated for 5 min.
PhonophoresisDevice
It will be consisted of 1 MHz pulsed mode with an intensity set at 1.5 W/cm2 and. A 5 cm2 crystal head with an effective radiating area of 4.0 cm2 ±1.0 wills utilized for 5 Min for each trigger point of neck. lidocine gelwill applied instead of coupling US gel used for transmission.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Treatment Arm | Active comparator | conventional physical therapy program (infrared, stretching exercise, isometric strengthening exercise) Receives: Other: Conventional physical therapy program |
| IASTM treatment arm | Experimental | Instrument-assisted soft tissue mobilization (IASTM) is a therapeutic technique that is based on the soft tissue mobilization rationale introduced by James Cyriax. Receives: Other: Conventional physical therapy program; Other: IASTM by M2t blade |
| Phonophoresis treatment arm | Experimental | It will be consisted of 1 MHz pulsed mode with an intensity set at 1.5 W/cm2. Receives: Other: Conventional physical therapy program; Device: Phonophoresis |
| Combined IASTM and phonophoresis treatment arm | Experimental | Combined phonophoresis and M2t Blade Receives: Other: Conventional physical therapy program; Other: IASTM by M2t blade; Device: Phonophoresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the change in pain intensity
assessment via using visual analogue scale (VAS) most commonly consists of a 100mm horizontal line anchored with two opposite labels; patients mark a score on the scale using a vertical line. A VAS is easy to use and therefore applicable to a variety of practice and research settings. (0 means no pain \& 10 means highest pain intensity).
Measured: Baseline and 4 weeks post-intervention
Assessing the change in neck disability
assessment via using Neck disability index: The NDI can be scored as a raw score or doubled and expressed as a percent. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. All the points can be summed to a total score. The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage.
0 points or 0% means: no activity limitations, 50 points or 100% means complete activity limitation,Mean duration of the test: 3 to 7.8 minutes some benchmarks can be found in literature, Vernon and Moir presented the following interpretation: 0-4points (0-8%) no disability. 5-14points (10-28%) mild disability. 15-24points (30-48%) moderate disability. 25-34points (50-64%) severe disability. 35-50points (70-100%) complete disability.
Measured: Baseline and 4 weeks post-intervention
Assessing the change in Pain Pressure Threshold
assessment via using Pressure algometer: Pain Pressure Threshold (PPT) was measured by an algometer using a 1 cm2 disk surface area pressed vertically on MTrP. To provoke pain, pressure was increased with a speed of 1kg/cm2/s-1
Measured: Baseline and 4 weeks post-intervention
Assessing the change in frequency of headache
Headache frequency assessed after and before 12 sessions. It was defined as the number of headache days per week. The frequency of days with headache in the past weeks was registered by the participant
Measured: Baseline and 4 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start1 Jan 2021
- Primary completion1 Apr 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nada Gamal Saad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nada Gamal Saad, Cairo University
- Investigators
- Prof Abeer Yamany, Professor, Principal investigator, Cairo UniversityDr Mariam Omran, Lecturer, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950413
- Sponsor's protocol ID
- Nada_MSc
- Status last verified
- Jul 2021
- First submitted
- 28 Jun 2021
- Last updated
- 6 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Instrument-assisted Soft Tissue Mobilization and Phonophoresis on Trigger Points of Tension Headache
- ClinicalTrials.gov ID
- NCT04950413
- Acronym / sponsor ID
- Nada_MSc
- Conditions
- Headache, Tension-Type Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nada Gamal SaadUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 6 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
General purpose:
It was investigate the effect of IASTM and phonophoresis on Tension Type headache.
Specific Purpose:
- It was investigate the effect of IASTM on headache frequency, PPT, pain intensity, and functional disability on trigger points of tension type headache.
- It was investigate the effect of Lidocaine phonophoresis on headache frequency, PPT, pain intensity and functional disability on trigger points of tension type headache.
- It was investigate the effect of IASTM and Lidocaine phonophoresis on headache frequency, PPT, pain intensity, and functional disability on trigger points of tension type headache.
Detailed description
Phonophoresis is the use of therapeutic ultrasound to increase percutaneous drug absorption Percutaneous administration offers many benefits such as steady plasma levels, lack of degradation by the gastrointestinal system, and lack of liver effects (first-pass drug metabolism) on drug molecules. Transdermal drug delivery offers a unique opportunity for non-invasive and controlled drug delivery, in contrast to needle-based and oral drug administration. Phonophoresis is a therapeutic method that may be helpful for the treatment of MTP.
There are potentially adverse treatment responses to ISTM that may occur. The patient may experience discomfort during the administration of the treatment, and petechiae (i.e., bruising) may become apparent during or after the treatment Although discomfort may be experienced, patients who have realized a decrease in symptoms have returned repeatedly for additional ISTM sessions other therapeutic modalities should be administered for pain management.
Clinical and scientific evidence supports that proper management of patients with headache should be multimodal including appropriate use of pharmacological and non-pharmacological.IASTM used to facilitate normal alignment of soft tissue and increase fibroblast recruitment and regeneration of damaged tissue. Phonophoresis is frequently used to treat pain associated with muscular disorders, enhancing skin absorption of the topical medication's molecules. Study report that lidocaine decreases sensory input from mrofascialTrps and release local Tenderness by lowering the degree of the reflex mechanism responsible for referred pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Traditional Treatment Arm | Active comparator | Other: Conventional physical therapy programconventional physical therapy program (infrared, stretching exercise, isometric strengthening exercise) |
| IASTM treatment arm | Experimental | Other: Conventional physical therapy program, Other: IASTM by M2t bladeInstrument-assisted soft tissue mobilization (IASTM) is a therapeutic technique that is based on the soft tissue mobilization rationale introduced by James Cyriax. |
| Phonophoresis treatment arm | Experimental | Other: Conventional physical therapy program, Device: PhonophoresisIt will be consisted of 1 MHz pulsed mode with an intensity set at 1.5 W/cm2. |
| Combined IASTM and phonophoresis treatment arm | Experimental | Other: Conventional physical therapy program, Other: IASTM by M2t blade, Device: PhonophoresisCombined phonophoresis and M2t Blade |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Their age ranged from 30 to 40 years.
- BMI ranged from 18 to 25 kg /m2.
- TTH criteria according to the Headache Classification Committee of the International Headache Society has at least two of the following characteristics:
- Bilateral location.
- Pressing/tightening quality (non-pulsating).
Key exclusion criteria (7 listed)
- Patients with a history of malignancy.
- Patients who had a history of cervical and cranial Surgery.
- Patients with major psychiatric disorders (major Depression).
- Patients with uncontrolled hypertension
- Patient with other causes of headache.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional physical therapy programInfrared, Exercises, Stretching exercise of Suboccepital muscle | Other | Combined IASTM and phonophoresis treatment arm, IASTM treatment arm, Phonophoresis treatment arm, Traditional Treatment Arm |
| IASTM by M2t bladeA lubricant (Vaseline) will be applied to the skin around the neck area prior to treatment and the M2t blade will be cleaned with an alcohol pad. First, the M2T blade will used to find the exact areas of restriction in affected muscles. Then the M2T blade will use at an angle of 45 to apply slow strokes along the muscle. Changes in soft tissue consistency will detected by the clinician through vibrations of the instrument when it slides on areas of irregular fibrosis of the underneath connective tissue. Once an adhesion is discovered, strokes are repeated for 5 min. | Other | Combined IASTM and phonophoresis treatment arm, IASTM treatment arm |
| PhonophoresisIt will be consisted of 1 MHz pulsed mode with an intensity set at 1.5 W/cm2 and. A 5 cm2 crystal head with an effective radiating area of 4.0 cm2 ±1.0 wills utilized for 5 Min for each trigger point of neck. lidocine gelwill applied instead of coupling US gel used for transmission. | Device | Combined IASTM and phonophoresis treatment arm, Phonophoresis treatment arm |
Primary outcome
Assessing the change in pain intensity
Time frame: Baseline and 4 weeks post-intervention
assessment via using visual analogue scale (VAS) most commonly consists of a 100mm horizontal line anchored with two opposite labels; patients mark a score on the scale using a vertical line. A VAS is easy to use and therefore applicable to a variety of practice and research settings. (0 means no pain \& 10 means highest pain intensity).
Assessing the change in neck disability
Time frame: Baseline and 4 weeks post-intervention
assessment via using Neck disability index: The NDI can be scored as a raw score or doubled and expressed as a percent. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. All the points can be summed to a total score. The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage. 0 points or 0% means: no activity limitations, 50 points or 100% means complete activity limitation,Mean duration of the test: 3 to 7.8 minutes some benchmarks can be found in literature, Vernon and Moir presented the following interpretation: 0-4points (0-8%) no disability. 5-14points (10-28%) mild disability. 15-24points (30-48%) moderate disability. 25-34points (50-64%) severe disability. 35-50points (70-100%) complete disability.
Assessing the change in Pain Pressure Threshold
Time frame: Baseline and 4 weeks post-intervention
assessment via using Pressure algometer: Pain Pressure Threshold (PPT) was measured by an algometer using a 1 cm2 disk surface area pressed vertically on MTrP. To provoke pain, pressure was increased with a speed of 1kg/cm2/s-1
Assessing the change in frequency of headache
Time frame: Baseline and 4 weeks post-intervention
Headache frequency assessed after and before 12 sessions. It was defined as the number of headache days per week. The frequency of days with headache in the past weeks was registered by the participant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof Abeer Yamany, Professor principal investigator
Cairo University
Dr Mariam Omran, Lecturer study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional physical therapy program, IASTM by M2t blade and Phonophoresis in people with Headache and Tension-Type Headache, run by Nada Gamal Saad at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the change in pain intensity (time frame: Baseline and 4 weeks post-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2021.